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OMER

Omeros

$20.16

-0.98 (-4.64%)

08:36
07/25/18
07/25
08:36
07/25/18
08:36

Omeros says OMS721 receives European Orphan Drug designation positive opinion

Omeros Corporation announced that the European Medicines Agency's Committee for Orphan Medicinal Products issued a positive opinion recommending orphan drug designation of OMS721 for treatment in hematopoietic stem cell transplantation. OMS721 is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, the effector enzyme of the lectin pathway of the complement system. Three OMS721 Phase 3 clinical programs are progressing across hematopoietic stem cell transplant-associated thrombotic microangiopathy, immunoglobulin A nephropathy, and atypical hemolytic uremic syndrome. The positive opinion is expected to be published by COMP within the week and to be adopted by the European Commission in August. Orphan Drug Designation in Europe is available to companies developing products intended to treat a life-threatening or chronically debilitating condition that affects fewer than five in 10,000 persons in the EU. This designation allows for financial and regulatory incentives that include 10 years of marketing exclusivity in the EU after product approval, reduced EMA advisory, inspection and filing fees pre- and post-approval, and guaranteed access to centralized marketing authorization valid in all EU member states as well as in the European Economic Area countries.The U.S. FDA earlier granted orphan designation to OMS721 for the prevention of complement-mediated TMA and, in April of this year, granted breakthrough therapy designation to OMS721 for the treatment of stem cell-transplant patients who have persistent TMA despite modification of immunosuppressive therapy. Discussions are ongoing with both U.S. and European regulators regarding expedited pathways to approval for OMS721 in the treatment of "high-risk" stem cell transplant-associated TMA.

OMER Omeros
$20.16

-0.98 (-4.64%)

03/22/18
MAXM
03/22/18
NO CHANGE
Target $25
MAXM
Buy
Omeros short-term reimbursement overhang removal 'great news,' says Maxim
Maxim analyst Jason McCarthy said Omeros resolution of of reimbursement "pass through" status removes an overhang. McCarthy expects Omidria to return to its previous trend of growing sales, and raised his estimates for 2018 to account for the news, while increasing his price target to $25 from $24 and reiterating a Buy rating on Omeros shares
03/23/18
WEDB
03/23/18
DOWNGRADE
Target $19
WEDB
Neutral
Omeros downgraded to Neutral from Outperform at Wedbush
Wedbush analyst Liana Moussatos downgraded Omeros to Neutral and lowered her price target for the shares to $19 from $47. The analyst sees a "lack of clarity for the financial status" with disruption in Omidria sales and the company's inability to fund progress with its top potential value driver OMS721. Even with possible extension of Omidria pass-through reimbursement for two additional years starting in October 2018, sales are unlikely to fund the pipeline in 2018 and 2019, Moussatos tells investors in a research note. Omeros closed yesterday up 35%, or $4.11, to $15.75.
03/23/18
HCWC
03/23/18
NO CHANGE
Target $34
HCWC
Buy
Omeros price target raised to $34 from $30 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Omeros to $34 after Omidria pass-through reimbursement status was extended. The language in the spending bill provides the extension for a period of two years, Selvaraju tells investors in a research note. This is an "unexpected success" for Omeros, and should lead to a "significant rebound" in Omidria sales and resumption of growth in the franchise, Selvaraju writes. He reiterates a Buy rating on Omeros shares.
07/12/18
GHSC
07/12/18
INITIATION
Target $30
GHSC
Buy
Omeros initiated with a Buy at Seaport Global
Seaport Global analyst Corey Davis initiated Omeros with a Buy and $30 price target saying Omidria for cataract surgery regains pass-through starting October 1 following new legislation. Davis expects the company to quickly return to an annualized run-rate of $87M, and if it secures permanent reimbursement from CMS, likely $200M-$400M in peak sales.

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NASDAQ Market Internals

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UNIT

Uniti Group

$8.55

-0.03 (-0.35%)

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TELL

Tellurian

$6.99

0.32 (4.80%)

13:05
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Tellurian call volume above normal and directionally bullish »

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Stephens architecture analysts to hold analyst/industry conference call nosymbol »

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EMR

Emerson

$64.26

-0.4 (-0.62%)

12:55
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Options
Emerson put volume heavy and directionally bearish »

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FB

Facebook

$200.15

-1.82 (-0.90%)

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DHR

Danaher

$141.79

2.19 (1.57%)

12:40
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Danaher analyst commentary at Piper Jaffray »

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AXP

American Express

$128.02

0.975 (0.77%)

, V

Visa

$179.16

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Earnings
Fly Intel: What to watch in credit card space earnings reports »

American Express (AXP),…

AXP

American Express

$128.02

0.975 (0.77%)

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Visa

$179.16

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MA

MasterCard

$275.83

0.49 (0.18%)

UBER

Uber

$43.74

0.12 (0.28%)

LYFT

Lyft

$65.51

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WU

Western Union

$20.42

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BBVA

Banco Bilbao

$5.42

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BUD

AB InBev

$88.73

0.31 (0.35%)

, KKR

KKR

$25.38

-0.08 (-0.31%)

12:36
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Periodicals
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BUD

AB InBev

$88.73

0.31 (0.35%)

KKR

KKR

$25.38

-0.08 (-0.31%)

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ESV

Ensco Rowan

$7.74

-0.16 (-2.03%)

12:35
07/18/19
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Options
Ensco put volume heavy and directionally bearish »

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CHS

Chico's

$3.29

-0.13 (-3.80%)

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Chico's FAS initiates Fort Myers lockdown after call over active shooter threat »

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CPE

Callon Petroleum

$4.87

-0.35 (-6.71%)

12:33
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Conference/Events
Callon Petroleum management to meet with JPMorgan »

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BUD

AB InBev

$88.64

0.22 (0.25%)

12:29
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Hot Stocks
Breaking Hot Stocks news story on AB InBev »

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BUD

AB InBev

$88.64

0.22 (0.25%)

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Periodicals
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UAL

United Continental

$94.94

0.11 (0.12%)

, BA

Boeing

$363.48

-5.97 (-1.62%)

12:28
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UAL

United Continental

$94.94

0.11 (0.12%)

BA

Boeing

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-5.97 (-1.62%)

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Conference/Events
William Blair enterprise & cloud infrastructure analyst to hold a group luncheon »

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BA

Boeing

$363.39

-6.06 (-1.64%)

12:24
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Periodicals
Some Boeing planes may be prone to cell phone interference, Bloomberg says »

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MBUU

Malibu Boats

$35.98

-0.7 (-1.91%)

12:23
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SBPH

Spring Bank Pharmaceuticals

$5.59

0.48 (9.39%)

, ARWR

Arrowhead

$29.53

0.99 (3.47%)

12:22
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Spring Bank Pharmaceuticals, Arrowhead, Johnson & Johnson, Gilead analyst commentary at Piper Jaffray »

Spring Bank research…

SBPH

Spring Bank Pharmaceuticals

$5.59

0.48 (9.39%)

ARWR

Arrowhead

$29.53

0.99 (3.47%)

JNJ

Johnson & Johnson

$131.79

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GILD

Gilead

$66.86

-0.05 (-0.07%)

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AKZOY

AkzoNobel

$0.00

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PPG

$116.71

0.105 (0.09%)

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Periodicals
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AkzoNobel

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$116.71

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Axalta Coating

$30.40

0.18 (0.60%)

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